NCT01210612

Brief Summary

Lateral ankle sprain (LAS) is one of the most common injuries in sports. There is a unique style of socks that have become popular in Japan among athletes that could also improve postural control. The purpose of the study is to determine the effectiveness of five-toed socks on dynamic postural control in individuals with and without chronic ankle instability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 28, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
13.7 years until next milestone

Results Posted

Study results publicly available

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

July 1, 2024

Enrollment Period

Same day

First QC Date

June 23, 2010

Results QC Date

August 21, 2012

Last Update Submit

July 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Primary Outcome Measurement for This Study Was to Determine Differences in Center of Pressure (COP) and Static Postural Control Patterns in Individuals With and Without CAI During the Single Limb Balance Test.

    Participants were recruited to complete three testing sessions, separated by approximately one week. The participants were tested while wearing five-toed socks. Static postural control was assessed on a force plate (model 4060NC; Bertec Corp. Inc., Columbus, OH) with the subject in a single-limb stance. Center of Pressure (COP) data were sampled at 50Hz. The subjects completed three 15-second trials with a one-minute rest between trials. Motion Monitor software (Innovative Sports Training, Inc., Chicago, IL) collected COP data during the single-limb stance test. The primary outcome was COP-Velocity (cm/sec).

    3 weeks

Secondary Outcomes (1)

  • Reaching Distances

    3 weeks

Study Arms (2)

Without Unilateral CAI

ACTIVE COMPARATOR

Individuals with no history of chronic ankle instability (CAI)

Device: Unilateral CAI

With Unilateral CAI

EXPERIMENTAL

Individuals with a history of chronic ankle instability (CAI) that is affecting only one limb

Device: Unilateral CAI

Interventions

five-toed socks usage

With Unilateral CAIWithout Unilateral CAI

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • member of university community
  • All subjects will be physically active (at least 30 minutes of sustained exercise 3 times/week

You may not qualify if:

  • history of: knee or hip musculoskeletal injury or surgery
  • history of: fracture or dislocation of the testing ankle or leg
  • neurological problems
  • vestibular disorders or concussions within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toledo

Toledo, Ohio, 43614, United States

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Limitations and Caveats

The day-to-day diurnal effect has been recognized as an important factor to consider when measuring postural control. We, however, did not consider day-to-day influences in postural control. This may have influenced the data we have collected.

Results Point of Contact

Title
Phillip Gribble
Organization
University of Toledo Health Science Campus

Study Officials

  • Phillip Gribble

    University of Toledo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 23, 2010

First Posted

September 28, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

August 13, 2024

Results First Posted

August 13, 2024

Record last verified: 2024-07

Locations